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NDC 35356-0647-30 speedgel rx 1; 3; 1; 3; 1; 1; 1; 3; 3; 1; 1; 1; 1; 1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details
speedgel rx 1; 3; 1; 3; 1; 1; 1; 3; 3; 1; 1; 1; 1; 1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
speedgel rx is a TRANSDERMAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lake Erie Medical DBA Quality Care Products LLC. The primary component is ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; COLCHICINE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM .
Product Information
NDC | 35356-0647 |
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Product ID | 35356-647_3146b40b-8463-4bca-8dad-332590080733 |
Associated GPIs | 99870010004000 |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | speedgel rx |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM, ZINGIBER OFFICINAL |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | GEL |
Route | TRANSDERMAL |
Active Ingredient Strength | 1; 3; 1; 3; 1; 1; 1; 3; 3; 1; 1; 1; 1; 1 |
Active Ingredient Units | [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL |
Substance Name | ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; CHAMOMILE; COLCHICINE; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; GINGER; HAMAMELIS VIRGINIANA ROOT BARK/STEM |
Labeler Name | Lake Erie Medical DBA Quality Care Products LLC |
Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Cytochrome P450 3A4 Inhibitors [MoA], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC |
DEA Schedule | n/a |
Marketing Category | UNAPPROVED HOMEOPATHIC |
Application Number | n/a |
Listing Certified Through | 2022-12-31 |
Package
Package Images

NDC 35356-0647-30 (35356064730)
NDC Package Code | 35356-647-30 |
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Billing NDC | 35356064730 |
Package | 1 BOTTLE, DISPENSING in 1 CARTON (35356-647-30) / 30 mL in 1 BOTTLE, DISPENSING |
Marketing Start Date | 2013-08-23 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 28561a9a-8a1b-4113-b3bc-ff7e5b329b54 Details
DESCRIPTION
SPEEDGEL RX is a homeopathic topical analgesic gel that contains the ingredients listed below.Homeopathic ingredients have been used since the inception of this science and remain as an effective method of treating select conditions. It is an amber colored odorless gel for use externally to control inflammation and reduce pain.
It contains the following active ingredients:
Aconitum Napellus 3X, Arnica Montana 3X, Belladonna 3X, Bellis Perennis 1X, Calendula Officinalis 1X, Colchicinum 3X, Chamomilla 1X, Echinacea Angustifolia 1X, Echinacea Purpurea 1X, Hamamelis Virginiana 1X, Hypericum Perforatum 1X, Millefolium 1X, Symphytum Officinale 3X, Zingiber Officinale 1X.
It also contains the following inactive ingredients:
Purified water, Urea, Isopropyl myristate, Lecithin, Docusate sodium, Sodium hydroxide.
CLINICAL PHARMACOLOGY
The exact pharmacology by which SpeedGel RX works to control aches and pains associated with arthritis or trauma (such as sprains, strains, dislocations, repetitive/overuse injuries, traumatic edema, post-surgical edema, hematoma, general swelling of joints and soft tissues) to such areas as hands, wrist, elbow, shoulder, neck, back, knees, ankles, feet and toes is unknown. It is theorized that, according to traditional homeopathy, the following ingredients contribute in the following ways:
Ingredients | Common Name | Indications |
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Aconitum Napellus |
Monk’s-hood |
Neuralgia, rheumatism, hemostasis, analgesia |
Arnica Montana |
Mountain arnica |
Stimulates healing of injured tissues, wounds, contusions, hematomas, neuralgia, myalgia, analgesia |
Belladonna |
Deadly nightshade |
Inflammation locally |
Bellis Perennis |
Daisy |
Dislocations, bruising, reducing edema |
Calendula Officinalis |
Calendula |
Analgesia, inflammation |
Colchicinum |
Colchicine |
Inflammation and gout |
Chamomilla |
Chamomile |
Inflammation, promotes healing of tissues |
Echinacea Angustifolia |
Narrow leaf cone flower |
Inflammation and inhibits hyaluronidase |
Echinacea Purpurea |
Purple cone flower |
Stimulates fibroblasts, inflammation |
Hamamelis Virginiana |
Witch-hazel |
Astringent, analgesic, hematomas |
Hypericum Perforatum |
St. John’s wort |
Neuropathic pains |
Millefolium |
Yarrow |
Hematomas, wound healing |
Symphytum Officinale |
Comfrey |
Neuropathy, causalgia, contusions, periostitis |
Zingiber Officinale |
Ginger |
Inflammation |
INDICATIONS AND USAGE
SPEEDGEL RX is indicated for the relief of pain and inflammation from: arthritis or injuries such as sprains, strains, dislocations, repetitive/overuse injuries, traumatic edema, post-surgical edema, general swelling of joints and soft tissues of the hand, wrist, elbow, shoulder, neck, back, knee, ankle, foot and toe and general aches and pains.
WARNINGS
For external use only. Direct patient not to ingest SPEEDGEL RX and to avoid contact with the eyes and mucous membranes, wounds, and damaged skin. If condition worsens, or if symptoms persist for more than seven days or clear up and occur again within a few days, patient should consult a doctor. If a rash develops, patient should discontinue use until rash clears. After the disappearance of rash, patient can try SPEEDGEL RX again on a test area and monitor the site for additional results. If no rash or redness results, then patient can resume use. However, if the rash persists or redevelops, use should be discontinued.
Direct patient to keep this product out of reach of children and seek medical help or contact a Poison Control Center immediately if swallowed.
PRECAUTIONS
ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION
HOW SUPPLIED/STORAGE AND HANDLING
INGREDIENTS AND APPEARANCE
SPEEDGEL RX
echinacea angustifolia, echinacea purpurea, aconitum napellus, arnica montana, calendula officianalis, hamamelis virginiana, belladonna, bellis perennis, chamomillia, millefolium, hypericum perforatum, symphytum officinale, colchicinum, zingiber officinale gel |
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Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Lake Erie Medical DBA Quality Care Products LLC | 831276758 | relabel(35356-647) |